At a glance
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Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies
In Brief
A Phase 2 clinical trial evaluating KYMRIAH, YESCARTA, and 10 other interventions for Acute Lymphoblastic Leukemia and Large B-cell Lymphoma. Active but no longer recruiting, targeting 150 participants across 1 site.
Detailed Summary
This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. Patients will be assigned to Arm A and B based on age and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arm A and B separately.
Study Details
Timeline
Interventions
FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
CD19-directed genetically modified autologous T cell immunotherapy
30 mg/m2 IV daily for 4 doses
500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
30 mg/m2 IV daily for 3 doses
500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
25 mg/m2 i.v. daily for 3 days
250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.